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A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer


Phase 2
20 Years
74 Years
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer


Inclusion Criteria:



- Histologically and/or cytologically confirmed breast cancer

- Received prior chemotherapy for metastatic breast cancer with anthracycline and
taxane regimen

- To have at least one measurable region

- PS: 0-1

- To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

- To have Interstitial pneumonia or pulmonary fibrosis

- To have inflammatory carcinoma

- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the
latest hormonal/immunotherapy or 7 days after surgery

- To have brain metastasis with symptom

- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or
diabetes)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Description:

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

9065

NCT ID:

NCT00191269

Start Date:

June 2005

Completion Date:

March 2010

Related Keywords:

  • Metastatic Breast Cancer
  • after
  • anthracycline
  • taxane
  • regimen
  • Breast Neoplasms

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